Evaluating treatable traits in chronic obstructive airways disease

Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

This study is testing if personalized treatments based on specific traits can help people with chronic lung diseases like COPD, asthma, and cystic fibrosis feel better.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Leeds (Academic / other)
• Locations: 1 site (Leeds, Leeds)
• Trial ID: NCT05976919 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess treatable traits across various chronic obstructive airways diseases, including conditions like COPD, asthma, and cystic fibrosis. It focuses on using personalized medicine approaches to tailor therapies based on specific traits identified through pulmonary function testing and validated biomarkers. The study seeks to expand the understanding of these diseases beyond COPD and asthma, which have been the primary focus of previous research. Participants will include diagnosed patients and healthy controls, allowing for a comprehensive analysis of airway diseases.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-65 with a prior diagnosis of airway disease or healthy controls without respiratory issues.

Not a fit: Patients with recent severe exacerbations or contraindications to pulmonary function testing will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with chronic obstructive airways diseases.

How similar studies have performed: While there has been significant research on COPD and asthma, this study's focus on a broader spectrum of airway diseases represents a novel approach.

Eligibility criteria

Inclusion Criteria:

* Prior diagnosis of airways disease in accordance with European Respiratory Society guidelines.
* Non / ex-smokers (packs recorded as cigarettes per day / years smoked).
* Male or female aged 18-65 years
* Ability to provide written informed consent.
* Full comprehension of spoken and written English language.
* Cystic Fibrosis patients on triple CFTR modulators (90% cohort)
* Cystic Fibrosis patients on no CFTR modulators
* Healthy controls - entirely asymptomatic, no prior history of inhaler medication use and free from respiratory disease.

Exclusion Criteria:

* Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the past two months.
* Absolute or relative contraindications to cardio-pulmonary exercise testing or submaximal exercise testing.
* Absolute or relative contraindications to pulmonary function testing .
* Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e., pregnancy, recent contrast media administration or subject weight).
* Non-ambulant or musculoskeletal impairment that may affect activities of daily living or maximal exercise testing.
* Significant cognitive impairment (i.e., unable to provide written informed consent or safely / successfully perform tests).
* Currently receiving oxygen therapy.
* Inability to consent.
* Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccus infection.
* Lung transplantation
* Diagnosis of cardiovascular disease.
* Abnormal blood screening (anaemia, moderate / severe renal failure etc.)

Where this trial is running

Leeds, Leeds

• University of Leeds — Leeds, Leeds, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Oliver Price, PhD

Conditions Airway Disease